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A kind of preparation method of rotafoxine enteric-coated tablet

An enteric-coated tablet and fuxin sausage technology is applied in the field of preparation of rotafuxin enteric-coated tablets, which can solve problems such as complex mechanism and achieve the effects of uniform granulation, simple and efficient granulation process, and uniform material.

Active Publication Date: 2021-01-01
ZHAOKE PHARMA HEFEI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, recent studies have found that the mechanism is far more complex than originally thought

Method used

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  • A kind of preparation method of rotafoxine enteric-coated tablet

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] (1) Prescription composition

[0025] prescription Proportion in prescription (%) role in prescription Rotafusin 0.5 active ingredient pregelatinized starch 55.0 filler dextrin 15.0 filler gelatin 8.0 Adhesive Low-substituted hydroxypropyl cellulose 5.0 disintegrant stearic acid 2.0 Surfactant talcum powder 2 lubricant purified water 40 solvent Gastric film coating premix 3％ subcoat layer Enteric Film Coating Premix 10％ Enteric layer

[0026] (2) Preparation process

[0027] 1) Sieving: Pass the various auxiliary materials through a 60-mesh sieve respectively, and set aside.

[0028] 2) Weighing: Weigh the pregelatinized starch, dextrin, and gelatin according to the prescription and mix them for later use.

[0029] 3) Dissolution: Prepare stearic acid aqueous solution with a concentration of 1% in an appropriate container, then add rotafuxin into the stearic aqueous solutio...

Embodiment 2

[0036] (1) Prescription composition

[0037] prescription Proportion in prescription (%) role in prescription Rotafusin 0.50 active ingredient lactose 91.0 filler sodium alginate 4.0 Adhesive Croscarmellose Sodium 1.0 disintegrant Tween 80 0.5 Surfactant Calcium stearate 0.3 lubricant purified water 40 solvent Gastric film coating premix 5％ subcoat layer Enteric Film Coating Premix 15％ Enteric layer

[0038] (2) Preparation process

[0039] 1) Sieving: Pass the various auxiliary materials through a 100-mesh sieve respectively, and set aside.

[0040] 2) Weighing samples: Weigh lactose, sodium alginate, and croscarmellose sodium according to the prescription amount, and set aside.

[0041] 3) Dissolution: prepare a Tween 80 aqueous solution with a concentration of 5% in an appropriate container, and then add rotafucine into the 80 aqueous solution shown in the picture for ultrasonic dissol...

Embodiment 3

[0048] (1) Prescription composition

[0049] prescription Proportion in prescription (%) role in prescription Rotafusin 0.500 active ingredient Mannitol 79.00 filler microcrystalline cellulose 10.0 filler Hydroxypropyl Cellulose 5.0 Adhesive Crospovidone 3.0 disintegrant Sodium dodecyl sulfate 1.0 Surfactant Magnesium stearate 1.5 lubricant purified water 40 solvent Gastric film coating premix 3％ subcoat layer Enteric Film Coating Premix 10％ Enteric layer

[0050] (2) Preparation process

[0051] 1) Sieving: Pass the various auxiliary materials through an 80-mesh sieve respectively, and set aside.

[0052] 2) Weighing samples: Weigh mannitol, microcrystalline cellulose, hydroxypropyl cellulose, and crospovidone (half the amount of the prescription) according to the prescription amount, and set aside.

[0053] 3) Dissolution: prepare an aqueous solution of sodium lauryl sulfate wit...

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Abstract

The invention discloses a rostafuroxin enteric-coated tablet and a preparation method thereof. The preparation method comprises the following steps of (1) respectively screening 70% to 91% of filler,0.3% to 2% of lubricant, 4% to 8% of adhesive, 1% to 5% of disintegrant, and 0.5% to 2% of surfactant; mixing the filler and the adhesive to obtain a mixture; (2) adding pure water into the surfactantto prepare a surfactant water solution with concentration of 1% to 5%, adding 0.5% of rostafuroxin into the water solution, and dissolving by ultrasonic waves, so as to obtain a mixed solution; (3) atomizing and spraying the mixed solution obtained in step (2) into the mixture obtained in step (2), granulating the sprayed mixture, and drying, so as to obtain particles, wherein the percentage refers to the mass percentage of each component in the raw material; (4) granulating the particles obtained in step (3), adding the lubricant to uniformly mix, and tabletting, so as to obtain plain tablets; (5) coating the plain tablets for the second time, so as to obtain the enteric-coated tablet. The preparation method has the advantages that by adopting the preparation technique, the content of particle is uniform, the quality is stable, the loss amount is small, the technology process is simple, and the cost is effectively reduced.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to a preparation method of rotafoxine enteric-coated tablets. Background technique [0002] The main causes of hypertension are genetic factors, mental and environmental factors, age factors, lifestyle factors, drug effects and other diseases. About 60% of them have a family history of hypertension, so it is generally believed that it is caused by polygenic inheritance. If patients with high blood pressure cannot receive timely and effective treatment, they may increase the risk of heart failure, stroke and renal failure. [0003] The pathogenesis of hypertension is generally believed to be caused by sodium retention. However, recent studies have found that its mechanism is far more complex than originally thought. Many studies suggest that although other cardiac hormones, such as digoxin, are also present in human and animal plasma and tissues, only plasma endogenous ouabain...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K31/58A61K47/42A61K47/36A61K47/38A61P9/12
CPCA61K9/2054A61K9/2059A61K9/2063A61K9/2886A61K31/58
Inventor 陈倩欣张莹莹李小羿戴向荣殷雷凌娟
Owner ZHAOKE PHARMA HEFEI
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